Anesthesia Regimens for Hip Replacement Surgery

(BCIS Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Severe aortic stenosis, Anticoagulation, Severe cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day (hospitalization with index surgery)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different anesthesia methods affect individuals undergoing hip surgery, focusing on a condition called bone cement implantation syndrome (BCIS). BCIS can lead to serious complications such as breathing problems, irregular heartbeats, or even cardiac arrest during surgery. The trial compares two types of anesthesia: general anesthesia and neuraxial anesthesia, which numbs the lower body. Researchers aim to determine which method is safer and causes fewer complications. Individuals needing hip surgery who have experienced breathing or heart issues during surgery may find this study relevant. As an unphased trial, this study offers a unique opportunity to contribute to understanding anesthesia safety in hip surgery.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study linked spinal anesthesia to lower risks of death, confusion, and major medical problems. This type of anesthesia might also reduce the chances of in-hospital death and serious breathing issues. Another study found that spinal anesthesia, even when combined with general anesthesia, showed positive results, although it increased the need for blood transfusions.

For general anesthesia, one study suggested benefits for lung health. However, using general anesthesia in hip surgeries might be associated with a shorter life expectancy and a higher chance of lung infections. Some studies have found that both types of anesthesia have similar death and complication rates, indicating comparable overall safety.

In summary, both spinal and general anesthesia have their pros and cons. Spinal anesthesia might be safer for certain risks, while general anesthesia might benefit lung health. It's important to consider these options and discuss them with a doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comparing anesthesia regimens for hip replacement surgery because they aim to uncover differences in outcomes between neuraxial anesthesia and general anesthesia. Neuraxial anesthesia is unique because it targets the spinal nerves directly, which can reduce the need for systemic medications and potentially decrease recovery time. On the other hand, general anesthesia affects the entire body and is the current standard for many surgeries, but it can come with more side effects and longer recovery periods. By exploring these distinct approaches, researchers hope to identify which method provides better pain control and fewer complications, ultimately improving patient experiences and outcomes.

What evidence suggests that this trial's anesthesia regimens could be effective for reducing BCIS?

This trial will compare the effects of neuraxial anesthesia and general anesthesia for hip replacement surgery. Research has shown that neuraxial anesthesia for hip surgeries can lead to better outcomes than general anesthesia. Specifically, studies have found that neuraxial anesthesia can shorten hospital stays and speed up recovery. It also tends to cause fewer complications, such as heart issues, and has lower death rates within 30 days after surgery. In contrast, general anesthesia may lead to more complications and longer surgery times. Overall, neuraxial anesthesia might be a safer choice with fewer risks for patients undergoing hip surgery. ^{1 2 3 6 7}

Who Is on the Research Team?

Adam S. Levin, MD

Principal Investigator

Johns Hopkins Hospital, Dept Orthopedic Surgery, Baltimore, MD 21287

Are You a Good Fit for This Trial?

This trial is for older adults with hip fractures needing cemented hemiarthroplasty. It's not specified who can't join, but typically those with allergies to anesthesia or high risk for surgery complications might be excluded.

Exclusion Criteria

I am unable to understand and give consent due to severe cognitive issues.

I cannot have certain anesthesia due to my other health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo cemented hip hemiarthroplasty under either general or neuraxial anesthesia

1 day (hospitalization with index surgery)

1 visit (in-person)

Postoperative Monitoring

Postoperative complications within 30 days of the index surgery will be identified via chart review

30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Administration of general anaesthesia
• Neuraxial Analgesia

Trial Overview The study compares general anesthesia versus neuraxial analgesia (spinal block) in preventing BCIS during hip surgery. It also looks at how these methods affect histamine and complement levels in the body.

How Is the Trial Designed?

Group I: Neuraxial Anesthesia Active Control 1 Intervention

Patients undergoing cemented hemiarthroplasty under neuraxial anesthesia

Group II: General Anesthesia Active Control 1 Intervention

Patients undergoing cemented hemiarthroplasty under general anesthesia

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

In a study of 45,874 patients undergoing hip fracture surgery, neuraxial anesthesia was associated with lower rates of postoperative complications (11.0%) compared to general anesthesia (12.9%).

After adjusting for various factors, general anesthesia was found to significantly increase the risk of postoperative morbidity (19% higher) and mortality (9% higher) compared to neuraxial anesthesia, suggesting that neuraxial anesthesia may lead to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

General versus Neuraxial Anesthesia on Clinical Outcomes in Patients Receiving Hip Fracture Surgery: An Analysis of the ACS NSQIP Database. Wang, MT., Chang, CC., Liu, CC., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4095027/

Perioperative outcomes and type of anesthesia in hip surgical ... With multi-modal anesthesia, minimal invasive-surgery and home rehabilitation it has been shown that up to 44.4% of patients following total hip arthroplasty ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2113514

Spinal Anesthesia or General Anesthesia for Hip Surgery ... Seven patients who had been assigned to general anesthesia (0.9%) withdrew consent before surgery; no outcome data were collected for these 7 patients after ...

3. journal.medtigo.com journal.medtigo.com/a-comprehensive-review-of-regional-vs-general-anesthesia-in-hip-surgery-efficacy-and-safety-outcomes/

A Comprehensive Review of Regional vs. General ... This literature review examines clinical studies comparing RA and GA in hip surgeries, focusing on pain scores, opioid consumption, complications, and ...

4. rapm.bmj.com rapm.bmj.com/content/49/1/4

Improved outcomes for spinal versus general anesthesia for ... General anesthesia was also associated with a higher frequency of 30-day mortality (OR 1.276 (95% CI 1.099 to 1.481); p=0.001) and longer operative time (64.73 ...

5. transpopmed.org transpopmed.org/articles/tppm/tppm-2024-11-184.php

Superiority of Regional or General Anesthesia for Hip ... An analysis of over 370,000 patients from 2006-2014 found a reduction in hospitalization cost of 15.6% (95% CI, 7.7 to 22.8) when neuraxial anesthesia was used ...

6. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1557053/full

Comparing general and regional anesthesia in patients ... Conclusion: Our study showed that both anesthesia types resulted in comparable mortality and complication rates in patients who underwent THA, ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0949265823000246

Effect of anaesthesia on cemented hemiarthroplasty General anaesthesia in cemented HA may be associated with lower life expectancy, increased incidence of pneumonia, and decreased walking ability.